Oncolytics is focused on the development of REOLYSIN®, an immuno-oncology (IO) viral agent (VA), to be used as a chemo-backbone and a potentially powerful adjuvant for other IO’s and target IMiD therapies.
REOLYSIN is a non-pathogenic, proprietary isolate of the unmodified reovirus and a first-in-class systemically administered immune-oncology viral agent for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.
The Company’s clinical development plan has two main objectives. The primary objective is to obtain regulatory approval for REOLYSIN as quickly as possible and is based on the compelling metastatic breast cancer survival data presented at the 2017 American Academy of Cancer Research (AACR) Annual Meeting. The second objective is to expand REOLYSIN into commercially valuable new treatment areas that include immunotherapy and immunomodulatory (IMiD) agents in collaboration with pharmaceutical partners.
REOLYSIN has been tested in multiple clinical studies ranging from single-arm translational to randomized late-stage. Indications studied include many prevalent forms of cancer including breast, non-small cell lung, colorectal and pancreatic, as well as multiple myeloma. REOLYSIN is safe and well tolerated with more than 1,000 patients treated to date, with no maximum tolerated dose reached and generally only mild or transient toxicities observed.
REOLYSIN is currently being manufactured at commercial scale in its final formulation under a commercial supply agreement with MilliporeSigma (formerly Sigma-Aldrich), the life science business of Merck KGaA. Under the current terms of the agreement, MilliporeSigma will manufacture all necessary product for clinical testing, as well as commercial product subject to the receipt of regulatory approval.
Oncolytics has more than 415 patents issued globally, including more than 60 in the U.S. and 20 in Canada, as well as numerous patents pending worldwide. Selected issued claims cover: compositions of matter comprising reovirus; combinations with therapies including radiation, chemotherapy and/or immune suppressants; and methods of manufacturing.